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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-506393-12-00 | Registry Identifier | EUCT number |
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The purpose of this study is to determine a safe and tolerable dose(s) of JNJ-86974680 for further research in combination with cetrelimab and radiation therapy.
Study consists of a screening period, treatment period (Part 1: dose escalation and Part 2: dose expansion), post-treatment follow-up period, and long-term extension period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: JNJ-86974680+Cetrelimab | Experimental | Participants will receive JNJ-86974680 alone (dose 1, dose 2, dose 3, and dose 4) daily in 4 cohorts and then along with a set dose of cetrelimab. |
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| Part 2: JNJ-86974680+Cetrelimab+Radiation Therapy (RT) | Experimental | Part 2 will consist of 3 cohorts (A, B and C) and participants will receive treatment with the selected dose of JNJ-86974680 in combination with cetrelimab from part 1, in conjunction with radiation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-86974680 | Drug | JNJ-86974680 will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) by Severity | An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. | Up to 2 years 5 months |
| Number of Participants with Dose Limiting Toxicities (DLTs) | The DLTs are specific adverse events and are defined as any of the following: non-hematologic toxicity and hematological toxicity. | Up to 2 years 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of JNJ-86974680 | Cmax is defined as maximum observed plasma concentration of JNJ-86974680. | Up to 2 years 5 months |
| Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC0-t) of JNJ-86974680 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 844-434-4210 | Participate-In-This-Study1@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Enterprise Innovation, Inc Clinical Trial | Johnson & Johnson Enterprise Innovation Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope 1 | Recruiting | Newnan | Georgia | 30265 | United States | |
| Hackensack University Medical Center |
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| Cetrelimab | Drug | Cetrelimab will be administered. |
|
| Radiation Therapy | Radiation | Radiation therapy will be administered. |
|
(AUC0-t) is defined as area under the plasma concentration of JNJ-86974680 versus time curve from the time of dose administration to time of last quantifiable concentration (0-t). |
| Up to 2 years 5 months |
| Part 2: Overall Response Rate (ORR) | ORR is defined as the percentage of participants who have a best response of complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST) version (v)1.1, maintained for at least 4 weeks. | Up to 2 years 5 months |
| Part 2: Complete Response Rate (CRR) | CRR is defined as the proportion of participants with a best response of CR. | Up to 2 years 5 months |
| Part 2: Duration of Response (DOR) | DoR is defined as the time from the date of first initial documentation of a response to the date of first documented evidence of progression of disease according to immunotherapy response evaluation criteria in solid tumors (iRECIST) or death due to any cause, whichever occurs first. | Up to 2 years 5 months |
| Part 2: Disease Control Rate (DCR) | DCR is defined as the percentage of participants who achieve a best of response of PR, CR, or stable disease using RECIST v1.1. | Up to 2 years 5 months |
| Recruiting |
| Hackensack |
| New Jersey |
| 07601 |
| United States |
| Roswell Park Comprehensive Cancer Center | Recruiting | Buffalo | New York | 14203 | United States |
| Herbert Irving Comprehensive Cancer Center Columbia University Medical Center | Recruiting | New York | New York | 10032 | United States |
| Providence Portland Medical Center | Recruiting | Portland | Oregon | 97213 | United States |
| Thomas Jefferson University | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
| Next Virginia | Recruiting | Fairfax | Virginia | 22031 | United States |
| Charite Research Organisation GmbH | Completed | Berlin | 12203 | Germany |
| Universitaetsklinikum Giessen und Marburg GmbH | Recruiting | Giessen | 35392 | Germany |
| Severance Hospital Yonsei University Health System | Recruiting | Seoul | 03722 | South Korea |
| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
| Hosp. Univ. Quiron Dexeus | Recruiting | Barcelona | 08028 | Spain |
| Hosp Univ Vall D Hebron | Recruiting | Barcelona | 8035 | Spain |
| Hosp. Univ. 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
| Hosp. Univ. I Politecni La Fe | Recruiting | Valencia | 46026 | Spain |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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